FDA recall D-0030-2021

4e Brands North America, Llc · Class I · drug

Product

blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bottle, Distributed in USA and Canada by: 4e Brands 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico. UPC 8 14266 02374 7

Reason for recall

Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.

Distribution

Distributed Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2020-07-11
Report date: 2020-10-07
Termination date: 2024-02-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Antonio, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0030-2021